Not Yet RecruitingNot Applicable

Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET/MRI for Lymph Node Staging in Rectal Cancer

30 participantsStarted 2026-04-01

Plain-language summary

This is a prospective, single-center, diagnostic study designed to compare the accuracy of \[68Ga\]Ga-CTR-FAPI PET/MRI and \[18\]F-FDG PET/MRI for the detection of lymph node metastasis in patients with initially untreated, resectable middle to high rectal cancer. The study aims to evaluate whether \[68Ga\]Ga-CTR-FAPI PET/MRI provides higher sensitivity and specificity than traditional 18F-FDG PET/MRI at both the patient level and the lymph node level.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed rectal adenocarcinoma by pathological biopsy. * Lower margin of the tumor is ≥ 5 cm and ≤15 cm from the anal verge. * Planned to undergo radical surgery. * ECOG performance status score ≤ 2. * Patient is willing to undergo PET/MRI examination. Exclusion Criteria: * History of pelvic radiotherapy or chemotherapy. * Concurrent with other malignant tumors or active infections. * Pregnant or unable to sign the informed consent form. * Claustrophobia or inability to tolerate MRI examinations due to other reasons.

What they're measuring

Sensitivity and Specificity of Lymph Node Metastasis Detection

Timeframe: Up to 30 days post-surgery

Trial details

NCT IDNCT07552207

SponsorPeking University Cancer Hospital & Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Minghe Zhao

0086-15600896700 dzhao3163@gmail.com

View on ClinicalTrials.gov More Rectal Cancer trials